SOP for Selecting Packaging Materials for Stability Studies

Department	Aerosol
SOP No.	SOP/Aerosol/104/2025
Supersedes	SOP/Aerosol/104/2022
Page No.	Page 1 of Y
Issue Date	06/02/2025
Effective Date	16/02/2025
Review Date	06/02/2028

1. Purpose

This Standard Operating Procedure (SOP) defines the process for selecting packaging materials for stability studies of aerosol products. The objective is to ensure that the packaging materials used in stability studies are suitable for maintaining the integrity of the product over time under specified storage conditions, and to guarantee that the selected materials comply with regulatory guidelines and provide accurate stability results.

2. Scope

This SOP applies to all aerosol products manufactured at [Company Name] that require stability testing. The procedure covers the selection of appropriate packaging materials for conducting stability studies, taking into account regulatory requirements, product compatibility, and the ability to protect the product during the stability testing process.

3. Responsibilities

• Packaging Team: Responsible for identifying and selecting the appropriate packaging materials based on the requirements for stability studies, including the product’s chemical and physical characteristics.
• Quality Assurance (QA) Team: Responsible for verifying that the selected packaging materials meet the necessary criteria and are suitable for stability testing. Ensures compliance with regulatory guidelines.
• Stability Testing Team: Responsible for conducting stability studies and ensuring that the selected packaging materials are properly used in the stability tests. Documents the results of the tests and ensures the integrity of the packaging materials throughout the study.
• Regulatory Affairs Team: Ensures that the packaging materials used in stability studies comply with relevant regulatory guidelines, including those set forth by the FDA, ICH, and other authorities.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the appropriate packaging materials are selected for stability studies. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Identification of Packaging Material Requirements

1. Before selecting packaging materials for stability studies, the following factors must be considered:
   • Product characteristics, including chemical composition, viscosity, and propellant type
   • Compatibility of the product with the packaging material (e.g., aerosol can, valve, actuator)
   • Potential impact of environmental conditions (e.g., temperature, humidity, light) on the product and packaging material
   • Regulatory requirements for the specific product type, including those for stability testing
2. The selected packaging materials must be suitable for preserving the quality, safety, and efficacy of the aerosol products during the stability testing period. The packaging must protect the product from light, moisture, and physical damage while also ensuring the product’s functionality (e.g., valve and actuator performance).

5.2. Selection Criteria for Packaging Materials

1. The following selection criteria should be used for determining appropriate packaging materials for stability studies:
   • The material must be inert and compatible with the formulation to prevent chemical reactions or degradation.
   • The material should provide an adequate barrier to moisture, air, and light to protect the product during storage.
   • The aerosol can should be able to withstand the temperature and humidity conditions used during the stability study without deformation or leakage.
   • The valve and actuator should be functional throughout the study, ensuring consistent product delivery.
   • The material should be compliant with regulatory requirements for stability testing (e.g., ICH Q1A, FDA guidelines).
2. Consultation with the R&D and production teams may be necessary to ensure that the selected packaging materials meet both product and regulatory requirements.

5.3. Packaging Material Samples for Stability Testing

1. Once the appropriate packaging materials are selected, the stability testing team should be provided with representative samples of the packaging materials, including cans, valves, actuators, and any secondary packaging (e.g., cartons).
2. Samples should be tested for:
   • Physical integrity (e.g., can strength, sealing quality, actuator function)
   • Compatibility with the product formulation under accelerated conditions (e.g., no corrosion, leakage, or contamination)
   • Conformance to regulatory guidelines (e.g., no interaction with the product that could affect its stability)
3. Documentation of packaging material performance during stability tests should be maintained in the Packaging Material Performance Log (Annexure-1).

5.4. Packaging Material Approval for Stability Studies

1. Once the packaging materials have been evaluated and tested, the QA team will review the test results and approve or reject the materials for use in stability studies. The following steps should be completed:
   • Review the compatibility and performance data of the packaging materials during stability testing.
   • Ensure that all regulatory requirements for packaging materials have been met.
   • Approve the packaging materials for stability testing or recommend changes if necessary.
2. The approved packaging materials should be used for the stability studies, and any modifications or rejections should be documented in the Packaging Material Review Log (Annexure-2).

5.5. Documentation and Record Keeping

1. All documentation related to the selection and approval of packaging materials for stability studies should be maintained for future reference and regulatory audits. Key documents include:
   • Packaging Material Selection Criteria Log (Annexure-1)
   • Packaging Material Review Log (Annexure-2)
   • Packaging Material Performance Log (Annexure-3)
2. Records should be signed and dated by the personnel involved in the selection and approval process. These records should be stored in the document management system for future reference and regulatory inspections.
3. Packaging material records should be retained for a minimum of 3 years or as required by regulatory guidelines.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• ICH: International Council for Harmonisation
• CFR: Code of Federal Regulations

7. Documents

1. Packaging Material Selection Criteria Log (Annexure-1)
2. Packaging Material Review Log (Annexure-2)
3. Packaging Material Performance Log (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• International Council for Harmonisation (ICH) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Packaging Material Selection Criteria Log

Material Type	Selection Criteria	Approval Status	Remarks
Aerosol Can	Must withstand 40°C for 6 months	Approved	No defects, meets required specifications

Annexure-2: Packaging Material Review Log

Material Type	Review Date	Reviewed By	Approval Status	Comments
Aerosol Can	10/02/2025	Anjali Sharma	Approved	All parameters met

Annexure-3: Packaging Material Performance Log

Material Type	Test Date	Test Result	Operator Name	Remarks
Aerosol Can	10/02/2025	Pass	Rajesh Patel	No visible defects

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated packaging selection criteria	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures